Client & Dates
European Pharmaceutical Company (Confidential) | July 2025
Client Challenge
A major European pharmaceutical manufacturer faced severe operational delays, high manual labor demands, and risk of knowledge loss within its global Chemistry, Manufacturing, and Controls (CMC) regulatory variation process.
BethAri’s Role
Lead digital quality consultancy engaged to map CMC workflows, evaluate automation feasibility, and design an AI-enabled implementation roadmap.
Approach
Step-by-step process mapping, stakeholder interviews across regulatory affairs and site quality teams, time-and-motion effort modeling, and ranking automation opportunities by ROI and regulatory compliance safety.
Deliverables
A detailed workflow map, identification of 3 high-priority automation opportunities, data governance rules for automated systems, a 90-day implementation plan, and commercial business case modeling.
Evidenced Results
Following implementation of BethAri’s proposal, the client successfully streamlined its regulatory variation workflows, realizing recurring annual savings of over €2m a year.
Contributing Experts
Dr Chinedu Madichie (Lead) and Global Regulatory/Analytical Specialists.